Kornimate/medical-research-clean huggingface dataset:
avaperl1 study: a study of avastin (bevacizumab) with or without pemetrexed as maintenance therapy after avastin in first line in patients with non-squamous non-small cell lung cancer

Conditions: Non-Squamous Non-Small Cell Lung Cancer

Summary: this open-label study will assess the efficacy and safety of avastin with or without pemetrexed as maintenance therapy in patients with advanced, metastatic or recurrent non-small cell lung cancer. in part 1, patients will receive 4 cycles of treatment with avastin (7.5mg/kg iv) plus cisplatin (75mg/m2 iv) plus pemetrexed (500mg/m2 iv) on day 1 of each 3-week cycle. in part 2, patients responding to treatment will be randomized to receive further treatment cycles of avastin (7.5mg/kg iv every 3 weeks) with or without pemetrexed (500mg/m2 iv every 3 weeks). anticipated time on study treatment is until disease progression. target sample size is \<500 individuals.


Eligibility criteria:
inclusion criteria: * adults \>/=18 years of age * inoperable, locally advanced, metastatic or recurrent non-squamous non-small cell lung cancer (nsclc) * at least 1 measurable lesion meeting recist criteria * ecog performance status 0-2 * adequate hematological, liver and renal function exclusion criteria: * prior chemotherapy or treatment with another systemic anti-cancer agent * malignancies other than nsclc within 5 years prior to randomization, except for adequately treated carcinoma in situ of the cervix, basal or squamous cell skin cancer, localized prostate cancer or dcis * evidence of tumor invading major blood vessels * current or recent use of aspirin (\>325mg/day) or full-dose anticoagulants or thrombolytic agents for therapeutic purposes * history of haemoptysis \>/=grade 2 * clinically significant cardiovascular disease
verification of the epidemiology and mortality of rare diseases in taiwan with real-world evidence

Conditions: Rare Diseases; Epidemiology; Morbidity; Morality; Comorbidities and Coexisting Conditions; Health Care Utilization

Summary: this study aims to explore the longitudinal incidence and prevalence trends of selected muscular and bone-related rare diseases, i.e., familial amyloidotic polyneuropathy (fap), primary hyperoxaluria, wilson's disease, cystic fibrosis, osteogenesis imperfecta, porphyria, and primary paget disease, and analyze healthcare utilization.

a rare disease (rd) means any disease that affects a small percentage of the population. according to the "rare disease and orphan drug act" in 2000, rd is defined as the prevalence of lower than 10,000 people in taiwan, or with special circumstances, and announced after review by the "review committee for rare diseases and orphan drugs". there are many different causes of rd, such as genetic and infection. although researchers have made progress in learning how to diagnose, treat, and even prevent a variety of rd, but there is still much to do because most rare diseases have no treatments. due to the low morbidity rate and fewer numbers of people who suffer from rd, patients have been impacted by a severe pathology and insufficiently recognized, diagnosed, and cured. however, prevalence, healthcare utilization, and economic impacts of rare diseases based on real-world evidence are still unknown in the world, especially in taiwan. in 2020, there were 226 diseases officially proclaimed as rd and 17,592 patients in taiwan, and approved 108 orphan drugs and 40 special nutrients for treating those patients to reduce their financial burden.

Eligibility criteria:
inclusion criteria: * the rd patients were defined as at least two ambulatory care records or one inpatient record in one year with familial amyloidotic polyneuropathy (fap), osteogenesis imperfecta, and acute hepatic porphyria between 2009 and 2017. exclusion criteria: * the rd patients were diagnosed with familial amyloidotic polyneuropathy (fap), osteogenesis imperfecta, and acute hepatic porphyria before 2009.
app-based optimization of long-term cpap adherence and quality of life

Conditions: Obstructive Sleep Apnea

Summary: the purpose of this study is to optimize the time of cpap usage to at least 6 hours a night for 6 nights per week for people who have osa with the help of a smartphone application called smartwell24. this application aims to target cpap adherence.


Eligibility criteria:
inclusion criteria: * in both trials of aim 2, twenty adults (≥18 years) per trial will be recruited who are newly diagnosed with osa and speak english. * in both trials, we will purposely recruit samples balanced by biological sex and osa severity (apnea hypopnea index: 5-14 vs. ≥ 15). * inclusion criteria are the same for both aim 2 trials; adult patients from mccsm sites who: * are diagnosed with osa based on clinical diagnostic testing via laboratory or home-based sleep study; * own and have the functional and cognitive ability to use an apple (ios9 or higher) or android (4.2 or higher) smartphone with minimal to no assistance; * are prescribed continuous or auto-titrated cpap; * agree to using a smartphone application and wearable wrist sensor; and * speak and read english. exclusion criteria: * unwilling to complete study measures and engage with sleepwell24; * refuse to not use the fitbit application during the study trial; * have any conditions that would impede full participation (e.g., communication or cognitive impairments that limit ability to read and/or follow directions, other acute or severe health, cognitive, or psychological conditions); * currently participating in other lifestyle programs (e.g. active, formal weight loss program or research study; smoking cessation program, etc.); * decide to use a different pap device than resmed airsense 10; * prescribed high-dose benzodiazepines (equivalent to \> 1 mg lorazapam/night); * daily opioid medication use at night;' * unwilling to discontinue use of any current wearable sensor for the duration of the trial; * previous documented history of treatment/referral for claustrophobia; * previous cpap use; * currently engaging in shiftwork defined as night shift or rotating day and night shifts; and * currently pregnant, trying to conceive, or breastfeeding.
evaluation of 18f-dcfbc psma-based pet imaging for detection of metastatic prostate cancer

Conditions: Metastatic Prostate Cancer

Summary: this research is being done to see if an investigational radioactive drug called 18f-dcfbc can help us find cancer that has spread (metastatic disease) from its original site in people who have cancer in their prostate to other parts of their body.

the objective of this study is to evaluate a radiolabeled urea-based small molecule inhibitor of prostate-specific membrane antigen (psma), \[18f\]dcfbc (dcfbc) pet imaging for detection of metastatic prostate cancer. psma is a well characterized histological marker of prostate cancer tumor aggressiveness and metastatic potential. the investigators propose to assess the ability of dcfbc pet to detect metastatic prostate cancer by visual qualitative and quantitative suv analysis. correlation will be made to sites of suspected metastatic disease detected by standard conventional imaging modalities (cim) for prostate cancer which includes iv contrast ct of chest/abdomen/pelvis and whole body bone scintigraphy.

Eligibility criteria:
inclusion criteria: 1. histological confirmation of prostate cancer 2. radiologic evidence of new or progressive metastatic disease demonstrated on anatomical imaging (ct, mri, or ultrasound), bone scintigraphy, \[18f\]sodium fluoride pet, and/or \[18f\]fdg pet 3. rising psa on two observations taken at least 1 week apart 4. adequate peripheral venous access or available central venous catheter access for radiopharmaceutical administration 5. patient can remain on androgen deprivation therapy if on the same regimen prior to documentation of progressive metastatic disease 6. patient cannot start a new therapy for prostate cancer prior to study radiopharmaceutical imaging 7. patient is judged by the investigator to have the initiative and means to be compliant with the protocol and be within geographical proximity to make the required study visits 8. patients or their legal representatives must have the ability to read, understand and provide written informed consent for the initiation of any study related procedures exclusion criteria: 1. patient has been treated with an investigational drug, investigational biologic, or investigational therapeutic device within 14 days prior to study radiotracer administration 2. prior radiation therapy, chemotherapy, or androgen-deprivation therapy within 2 weeks prior to study radiotracer administration (washout is one half-life of the drug or 2 weeks, whichever is longest) 3. initiation of new therapy for progressive metastatic disease since radiographic documentation of progression. 4. serum creatinine \> 3 times the upper limit of normal 5. total bilirubin \> 3 times the upper limit of normal 6. liver transaminases \> 5times the upper limit of normal 7. unable to lie flat during or tolerate pet/ct 8. prior history of any other malignancy within the last 2 years, other than skin basal cell or cutaneous superficial squamous cell carcinoma that has not metastasized and superficial bladder cancer.

Keywords: metastatic prostate cancer
the effect of non-invasive brian stimulation on language production in healthy older adults

Conditions: Language Disorders; Aphasia; Stroke

Summary: the use of non-invasive brain stimulation techniques like transcranial direct-current stimulation (tdcs) for rehabilitation of language is a growing field that needs further studies to determine how best it can be used to enhance treatment outcomes. it has been shown that tdcs can improve language performance in healthy and brain-injured individuals such as increased naming accuracy. however, at present, it is not known what effect tdcs has on higher-level language skills like discourse production (i.e. story telling, giving instructions) in healthy, older speakers. therefore, the aim of this study is to investigate in healthy older adults, the effect of tdcs on discourse production as well as the ideal tdcs electrode placement for improving language at the discourse level. it is hypothesised that tdcs will result in greater language changes and improvements during discourse production compared to no stimulation.


Eligibility criteria:
inclusion criteria: * at least 65 years of age * native english speakers * right handed * normal aided or unaided visual acuity * at least secondary school level of education exclusion criteria: * history of neurological disease or cognitive impairment * any contraindication of tdcs (i.e. history of seizures, metal implants)
initial combination of gemigliptin and metformin on microbiota change

Conditions: Diabetes

Summary: the purpose of this study is to investigate gut microbiota change and glucose lowering effect of initial combination therapy of gemigliptin and metformin compared to glimepiride and metformin in obese patients with type 2 diabetes.

obese type 2 diabetes patients who were not treated with anti-diabetic medication within 6 weeks, were randomly assigned to gemigliptin/metformin or sulphonylurea/metformin. after 24 week treatment, gut microbiota composition change, glucose lowering effect, body weight, and gut hormones were compared between two groups.

Eligibility criteria:
inclusion criteria: * type 2 diabetes * drug naive (no anti-diabetic medication within 6 weeks) * hba1c \>= 7.5% * bmi \>= 25.0 kg/m2 exclusion criteria: * type 1 diabetes * dka, hhs * history of hypersensitivity to sulphonylurea, metformin or dpp-4 inhibitor * gestational diabetes mellitus * serum cr \>1.5 mg/dl (male), \>1.4mg/dl (female) * abnormal liver function test * anti-obesity medication within 3 months * gastrointestinal motility drug, laxatives within 3 months * history of major gastrointestinal surgery
a social network aod intervention for homeless youth transitioning to housing

Conditions: Substance Use

Summary: this project will pilot test a computer-assisted social network intervention, using motivational interviewing techniques, that can help case managers work with formerly homeless young adults who recently transitioned to supportive housing to reduce substance use and increase permanent supportive connections during this critical transitional period.

the goal of this study is to conduct a pilot evaluation of a motivational network intervention (mni) to reduce substance use and strengthen supportive connections for recently homeless 18-25 year-olds who have transitioned to a housing program. the goal of this pilot study is to evaluate, through a small randomized controlled trial (stage 1b), the added benefit of incorporating the mni into case management for transitional age youth (tay) residents of housing programs. we hypothesized that residents receiving the mni as part of case management would show more positive changes in their substance use behaviors and the composition and structure of their personal networks (i.e., greater proportion of network members who are low-risk) over a 3-month follow-up period compared to residents receiving usual case management only.

Eligibility criteria:
inclusion criteria: * age 18-25 * in a housing program for homeless transition age youth * past month substance use * screen positive for past-year harmful substance use exclusion criteria: • not able to speak/understand english
performance evaluation of two daily disposable toric lens designs in habitual soft contact lens wearers

Conditions: Astigmatism

Summary: the objective of the study is to compare the clinical performance of two different daily disposable, sihy toric contact lens types, lens a and lens b, in existing soft lens wearers when worn for one week each.

this study is a prospective, bilateral eye, double-masked, randomized, 1-week cross-over, daily-wear design involving two different daily disposable toric lens types. each lens type will be worn for approximately one week, during which participants record their subjective lens-wear experience.

Eligibility criteria:
inclusion criteria: * is at least 18 years of age and has full legal capacity to volunteer; * has read and signed an information consent letter; * self reports having a full eye examination in the previous two years; * anticipates being able to wear the study lenses for at least 12 hours a day, 7 days a week; * is willing and able to follow instructions and maintain the appointment schedule; * habitually wears toric soft contact lenses binocularly, of any replacement frequency, for the past 3 months minimum; * has refractive astigmatism at least -0.75dc in each eye, maximum -2.25dc; * has refractive cylinder axis either between 155 to 25 or between 65 and 115 degrees; * is myopic and requires a spectacle spherical component of -1.00d to -6.50d inclusively; * can be fit and achieve binocular distance vision of at least 20/30 snellen with the available lens parameters exclusion criteria: * is participating in any concurrent clinical or research study; * habitually wears one of the study contact lenses; * has any known active ocular disease and/or infection that contraindicates contact lens wear; * has a systemic condition that in the opinion of the investigator may affect a study outcome variable; * is using any systemic or topical medications that in the opinion of the investigator may affect contact lens wear or a study outcome variable; * has known sensitivity to the diagnostic sodium fluorescein used in the study; * self-reports as pregnant, lactating or planning a pregnancy at the time of enrolment; * has undergone refractive error surgery or intraocular surgery.
peptide vaccine and s-1/cpt-11 therapy for patients with unresectable advanced colorectal cancer

Conditions: Colorectal Cancer

Summary: the purpose of this study is to evaluate the safety and immune response of different doses of rnf43-721 emulsified with montanide isa 51 in combination with s-1/cpt-11 chemotherapy.

rnf43 is a cancer testis antigen which express widely in colorectal cancer tissue but not in normal organs. rnf43-721 induces hla a24 restricted specific cytotoxic t lymphocytes (ctl) against rnf43 expressed target. s-1/cpt-11 chemotherapy is performed unresectable advanced colorectal cancer in japan and is reported to be obtained almost the same result compared with folfox or folfiri as first-line chemotherapy for advanced colorectal cancer. because synergistic effect between vaccine therapy and chemotherapy will be expected, we plan phase i study to evaluate the safety and immune response of different doses of rnf43-721 emulsified with montanide isa 51 in combination with s-1/cpt-11 chemotherapy.

Eligibility criteria:
inclusion criteria: * ecog performance status 0-1 * life expectancy \> 3 months * hla a24 positive * histologically diagnosed as colorectal cancer with measurable lesion * laboratory values as follows:wbc\>3000/mm3, hb\>10mg/dl, plt\>75000/mm3, creatinine\<1.2mg/dl, t. bil.\<1.5mg/dl, ast, alt\<3x normal limits * able and willing to give valid written informed consent exclusion criteria: * active other malignancy * active infection * immune deficiency * current treatment with steroids and immunosuppressive agents * pregnancy and breast feeding * inability oral intake * psychic disease * hepatitis b, c virus * hiv infection
inflammatory and microbiologic markers in sputum: comparing cystic fibrosis with primary ciliary dyskinesia

Conditions: Cystic Fibrosis; Primary Ciliary Dyskinesia

Summary: the objective of this study is to compare the lower airways inflammatory response to infection/pulmonary exacerbation among children known to have primary ciliary dyskinesia (pcd) with children known to have cystic fibrosis (cf) as measured by the presence of inflammatory mediators in expectorated/induced sputum.

the inflammatory response to infection and pulmonary exacerbation in cf is well documented, as is the response to intravenous antibiotic treatment. on the other hand, the inflammatory response to infection and treatment in pcd has not been well characterized. given differences in disease progression, we hypothesize that children with cf respond to infection with a more exaggerated and prolonged inflammatory response than those with pcd.

Eligibility criteria:
inclusion criteria: * diagnosis of cystic fibrosis (cf) as defined by two or more clinical features of cf and a documented sweat chloride \> 60 meq/l by quantitative pilocarpine iontophoresis test or a genotype showing two well characterized disease-causing mutations or a diagnosis of primary ciliary dyskinesia (pcd) as follows: definite pcd (compatible phenotype, diagnostic abnormality of ciliary ultrastructure and/or two disease-causing gene mutations) or "probable" pcd (compatible phenotype, ciliary biopsy not diagnostic but low nasal no (\<100nl/min) with negative investigation screen for both cf and immunodeficiency * informed consent and verbal assent (as appropriate) provided by the subject's parent or legal guardian and the subject * 6-18 years of age at enrolment and able to perform reproducible spirometry * clinically stable at enrolment (fev \> 30%, oxyhaemoglobin sats \> 93%) * ability to comply with study visits and study procedures exclusion criteria: * respiratory culture positive for non-tuberculous mycobacteria (ntm), stenotrophomonas maltophilia, aspergillus fumigatus, burkholderia cepacia complex, or pseudomonas aeruginosa within past year. * use of intravenous antibiotics or oral quinolones within previous 14 days * use of inhaled antibiotics within the previous 28 days * pneumothorax or haemoptysis

Keywords: pediatrics cf pcd exacerbation inflammatory markers induced sputum
development of a monitoring set-up and algorithm using functional mri (fmri) and eeg for prediction of response to repetitive deep transcranial magnetic stimulation (rdtms) for patients with parkinson's disease

Conditions: Parkinson

Summary: * to characterize physiological biomarkers of positive response to rdtms using eeg and functional mri (fmri) in patients with pd. * to develop a set-up and algorithm for neurophysiological monitoring for pd patients using eeg and fmri in patients treated by rdtms. * to integrate rdtms stimulation with monitoring techniques with the ultimate goal of providing closed-loop feedback where monitoring informs the stimulation

pd patients aged 40 years or older, diagnosed as idiopathic pd according to the uk brain bank criteria will be treated by an established rdtms protocol will be monitored before, during and after rdtms using quantitative eeg and brain network analysis and fmri while performing a series of cognitive and motor tasks.

Eligibility criteria:
inclusion criteria: 1. idiopathic pd patients aged 40-75 years; 2. hoehn and yahr stages ii to iv 3. patients on stable antiparkinsonian therapy for 1 month 4. right hand dominance with right afflicted side. exclusion criteria: 1. participation in current clinical study or clinical study within 30 days prior to this study. 2. subject has an atypical parkinsonian syndrome or secondary parkinsonism (e.g., due to drugs, metabolic neurogenetic disorders, encephalitis, cerebrovascular disease or other degenerative disease) 3. patients with significant psychiatric symptoms or history. 4. patients with psychotic symptoms or active depressive symptoms 5. treatment with neuroleptics. 6. beck depression inventory (bdi) score \<14 7. mini mental status examination (mmse) score \<25 8. history of migraine or frequent or severe headaches. 9. significant sensory deficits, e.g., deafness or blindness history of head injury or neurosurgical interventions. 10. subjects who have concomitant epilepsy, a history of seizure/s, heat convulsions or history of epilepsy in first degree relative. 11. history of any metal in the head (outside the mouth). 12. the presence of cochlear implants 13. known history of any metallic particles in the eye, implanted cardiac pacemaker, implanted neurostimulators, surgical clips (above the shoulder line) or any medical pumps. 14. subjects with an unstable medical disorder. 15. current drug abuse (including cannabis) or alcoholism. 16. pregnancy or not using a reliable method of birth control. 17. patients with severe tremor or dyskinesia

Keywords: parkinson tms bna
postoperative benefits of intraoperative nociception level (nol) titration - pilot

Conditions: Nociceptive Pain

Summary: previous work has shown that nol (medasense, ramat gan, israel) accurately quantifies nociception during general anesthesia. presumably, titrating opioids to nol will therefore provide individual guidance so that patients will be given about the right amount. patient given the right amount will presumably awaken quickly when anesthesia is done, and have good initial pain control in the post anesthesia care unit (pacu). to the extent that nol titration facilitates optimal opioid dosing, patients are likely to have better pacu experiences - which would be an important outcome that clinicians and regulators are likely to take seriously.


Eligibility criteria:
inclusion criteria: 1. adults having major non-cardiac surgery expected to last ≥2 hours; 2. american society of anesthesiologists physical status 1-3; 3. age 21-85 years old; 4. planned endotracheal intubation exclusion criteria: 1. planned neuraxial or regional block; 2. local anesthetic infiltration at surgical field; 3. clinician preference for an opioid other than, or in addition to, fentanyl; 4. non-sinus heart rhythm; 5. neurologic condition that, in the opinion of the investigators, may preclude accurate assessment of postoperative pain and nausea; 6. lack of english language fluency; 7. routine user of psychoactive drugs other than opioids; 8. contraindication to sevoflurane, fentanyl, morphine, or ondansetron. 9. intracranial surgery 10. bmi \> 40

Keywords: nol nociception